ClinPharm Vault
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria
Study Snapshot
- Program: Barzolvolimab
- Study ID(s): NCT04548869
- Phase: Phase 1
- Indication: Cold Urticaria, Cold Contact Urticaria, Symptomatic Dermographism, Symptomatic Dermatographism, Cholinergic Urticaria
- Status: Completed
- Sponsor: Celldex Therapeutics
Design
- Study type: INTERVENTIONAL
- Randomization / allocation: NA
- Intervention model: SINGLE_GROUP
- Masking: NONE
- Primary purpose: TREATMENT
- Enrollment: 41 (ACTUAL)
Population
- Conditions: Cold Urticaria, Cold Contact Urticaria, Symptomatic Dermographism, Symptomatic Dermatographism, Cholinergic Urticaria
- Sex: ALL
- Age range: 18 Years to 75 Years
- Healthy volunteers: False
- Summary: This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.
Operational design summary
- Arms represented in current CT.gov export: 1
- Active dose regimens represented in current local source layer: 1
- Total study enrollment in CT.gov: 41 (ACTUAL)
- Design interpretation: Single-dose open-label CIndU study using one active barzolvolimab regimen.
- Per-arm sample size summary: ClinicalTrials.gov arm description states planned enrollment of 20 Cold Contact Urticaria, 10 Symptomatic Dermographism, and 10 Cholinergic Urticaria patients; CT.gov lists 41 actual participants overall.
- Arm-size evidence source: ClinicalTrials.gov markdown arm description.
Arms
| Arm | Type | Dose | Frequency | Route | Description | N | Evidence status |
|---|---|---|---|---|---|---|---|
| CDX-0159 | EXPERIMENTAL | NR | Single dose | NR | 20 patients with Cold Contact Urticaria, 10 patients with Symptomatic Dermographism, and 10 patients with Cholinergic Urticaria will be enrolled and treated with a single dose of CDX-0159 | 41 | Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context |
Endpoints
- Primary outcomes:
- Safety as assessed by the incidence and severity of adverse events (time frame: From Day 1 through week 12)
Clinical Pharmacology Findings
- PK: ClinicalTrials.gov summary text indicates pharmacokinetics were part of the study objectives or assessments.
- PD: ClinicalTrials.gov summary text indicates pharmacodynamics were part of the study objectives or assessments.
- Linked manuscripts: No trial-level primary publication is explicitly linked in the current registry.
Safety Findings
- Safety detail is not strongly enriched beyond the current CT.gov/source-registry layer.
Linked Evidence
- CT.gov page: https://clinicaltrials.gov/study/NCT04548869
- Local CT.gov cache:
raw/clinicaltrials/markdown/NCT04548869.md
Interpretation
- Verified facts: this page reflects the current local registry and CT.gov inventory export without inferring unsupported arm sizes or endpoint results.
- Interpretation: this trial is currently represented mainly by CT.gov and any linked sponsor-source artifacts; manual enrichment is still needed for a richer narrative page.
- Open questions:
- Some studies still lack exact arm-specific N in the current promoted evidence layer even when allocation schema or total enrollment is visible.
- No explicit trial-level primary manuscript is currently linked in the registry.
- No sponsor artifact is explicitly linked to this trial by identifier in the current registry.
Provenance
- Source type: ClinicalTrials.gov inventory with linked sponsor/publication registry where available
- Primary source(s):
- NCT04548869
../raw/clinicaltrials/markdown/NCT04548869.md../inventories/source_registry.json- Supporting source(s):
../inventories/ctgov_priority_trials.json- Last verified: 2026-04-08
- Verification status: Partial
Change Log
- 2026-04-08: Generated or refreshed this study page from the v2 source registry and CT.gov inventory.